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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063901050
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2022
Event Type  malfunction  
Event Description
Basket was broken while using during procedure. The product was opened correctly passed off to the sterile field and started to use on pt by dr (b)(6). The product was found to be broken while in use. One of the wires on the basket was broken. Dr (b)(6) stopped using and replaced with new product. No harm to pt.
 
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Brand NameBOSTON SCIENTIFIC ZERO TIP NITINOL STONE RETRIEVAL BASKET
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key13307246
MDR Text Key284285197
Report NumberMW5106824
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063901050
Device Catalogue Number08714729469643
Device Lot Number28581788
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes

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